CN106456012A

CN106456012A - Method and apparatus for adjusting blanking period during transitioning between operating states in medical device

Info

Publication number: CN106456012A
Application number: CN201580034658.7A
Authority: CN
Inventors: S·E·格林哈特; R·W·斯塔德勒; 张绪省
Original assignee: Medtronic Inc
Current assignee: Medtronic Inc
Priority date: 2014-04-24
Filing date: 2015-04-14
Publication date: 2017-02-22
Anticipated expiration: 2035-04-14
Also published as: US20190232069A1; CN106456012B; US10252067B2; WO2015164127A3; WO2015164127A2; US11197630B2; EP3134177B1; EP3134177A2; US20150306408A1

Abstract

A method and medical device for adjusting a blanking period that includes sensing cardiac signals from a plurality of electrodes, the plurality of electrodes forming a plurality of sensing vectors, determining whether to adjust a blanking period during a first operating state, advancing from the first operating state to a second operating state in response to the sensed cardiac signals, determining, while in the second operating state, whether the blanking period was adjusted while in the first operating state, and adjusting the blanking period while in the second operating state in response to the blanking period being adjusted while in the first operating state.

Description

For adjusting the side of blanking interval in Medical Devices during the transformation between mode of operation Method and device

Technical field

The disclosure relates generally to implantable medical device, and relates more particularly to for selecting sensing in Medical Devices The apparatus and method of vector.

Background technology

Implantable medical device can be used for by delivering the anti-tachyarrhythmia pacemaker treats for making cardioversion or defibrillation To prevent with peb treatment or to treat arrhythmia cordis.It is commonly called as this apparatus senses of Implantable cardioverter-defibrillator or " ICD " The rhythm of the heart of patient is simultaneously classified to the described rhythm of the heart according to some rate field to be detected the outbreak event of tachycardia or fibrillation (episode).

Once abnormal heart rhythm is detected, ICD just delivers appropriate treatment.The pathomorphism of Ventricular Tachycardia often can lead to Cross anti-tachyarrhythmia pacemaker treats to terminate.Carry out high energy peb treatment if necessary after anti-tachyarrhythmia pacemaker treats.Logical Cross peb treatment and terminate tachycardia commonly known as " cardioversion ".Ventricular fibrillation (VF) is a kind of tachycardic form, It is a kind of situation of serious life-threatening, and generally treated by delivering high energy peb treatment immediately.The termination of VF generally quilt Referred to as " defibrillation ".Selecting appropriate treatment for effectively treating arrhythmia cordis and avoiding delivering unnecessary heart again Rule/defibrillation (CV/DF) electric shock (cardioversion/defibrillation shock is painful for patients) aspect, accurate arrhythmia cordis inspection Survey and distinguish it is important.

In the practice in past, icd system using by the endocardial electrodes carrying through transvenous lead for sense the heart Dirty electric signal simultaneously delivers electricity treatment.Emerging icd system is adapted under subcutaneous or flesh to implant and using combining in ICD housing On and/or the electrode that carried by lead under subcutaneous or flesh.Generally referred to herein as " subcutaneous ICD " or " SubQ ICD " system These systems of system do not rely on the electrode directly contact implanted with heart.Compared to the icd system using endocardial electrodes, SubQ icd system is less invasive and is therefore easier and quickly implants.However, bigger challenge is present in making Reliably detect arrhythmia cordis with subcutaneous system.R wave-amplitude in SubQ ECG signal can be shaking of the R ripple of the interior sensing of ventricle / 10th of width arrive one of percentage magnitude.Additionally, compared to heart heart electromyogram (EGM) signal, the ECG letter of subcutaneous sensing Number signal quality be likely to be more affected by myoelectric potential noise, the impact of ambient noise, patient's posture and patient activity.

Subcutaneous ICD detects that tachyarrhythmia and the ability of refusal noise depend on its ECG signal characteristic.Have relatively High amplitude R ripple ripple, upper frequency (high conversion rate) R ripple, higher R/T Bob, low frequency signals (for example, the P around R ripple Ripple and T ripple), the relatively hyposensitivity to bone myoelectric potential and the larger R ripple conforming ECG vector from cycle to cycle excellent Select in the ECG vector not having these attributes.There is minimum 2 bar ECG lead or vector in the planes (using 3 minimum electricity Pole) subcutaneous ICD can produce virtual ECG vector using these physical vectors using the linear combination of physical vector ECG.So And, in view of the environment of the change of subcutaneous system, select optimal vector can be sometimes a kind of challenge.Accordingly, it would be desirable to system and Method, described system and method can be promoted to the heart via subintegumental electrode sensing ECG signal with sensing vector using optimal Restrain not normal reliability and accurate sensing detection.

Brief description

Fig. 1 is the concept map of the patient being implanted with the outer defibrillating system of example blood vessel.

Fig. 2 is the electricity in airtight (hermetically) housing of sealing of subcutaneous according to an embodiment of the invention equipment The illustrative diagram of electronic circuit.

Fig. 3 be according to an embodiment in Medical Devices sensing vector selection course in along multiple sense to The figure measuring the heart signal sensing represents.

Fig. 4 is the flow chart according to exemplary embodiment for selecting the method for one or more sensing vectors.

Fig. 5 is the flow chart according to another exemplary embodiment for selecting the method for one or more sensing vectors.

Fig. 6 is the flow chart according to another exemplary embodiment for selecting the method for one or more sensing vectors.

Fig. 7 be according to another embodiment in Medical Devices sensing vector selection course in along multiple sense to The figure of the heart signal of amount sensing represents.

Fig. 8 is the flow chart according to another exemplary embodiment for selecting the method for one or more sensing vectors.

Fig. 9 is the state diagram of the ARR detection in Medical Devices according to an embodiment of the invention.

Figure 10 is in accordance with an embodiment of the present disclosure for adjusting blanking interval during the transformation between mode of operation The flow chart of the method for (blanking period).

Specific embodiment

Fig. 1 is the concept map of the patient 12 being implanted with the outer defibrillating system 10 of example blood vessel.Example shown in Fig. 1 In, the outer defibrillating system 10 of blood vessel is the subcutaneous ICD system of implantation.However, the technology of the disclosure also can be with other blood vessels The defibrillating system of outer implantation (such as has and is implanted in the heart of the lead under breastbone or in position under flesh at least in part and removes Quiver system) it is used together.In addition, the technology of the disclosure also can be used together with other embedded systems, other implanteds described System such as implanted pacing system, implantable nerve stimulating system, drug delivery system or wherein lead, conduit or other portions Part is implanted in the other system at the blood vessel external position in patient 12.However, for purpose of explanation, the disclosure is in implanted It is described in the context of the outer defibrillating system of blood vessel.

The outer defibrillating system 10 of blood vessel includes being connected to the implanted heart of at least one implantable cardiac defibrillation lead 16 Dirty cardioverter defibrillators (ICD) 14.The ICD 14 of Fig. 1 is implanted subcutaneously, there was on the left side of patient 12.It is connected to the defibrillation of ICD 14 Lead 16 medially extends from ICD 14 towards the breastbone 28 of patient 12 and xiphoid-process 24.At the position near xiphoid-process 24, defibrillation Lead 16 bends or turns and be arranged essentially parallel to breastbone 28 hypodermically goes up (superior) extension.Example shown in Fig. 1 In, defibrillation lead 16 is implanted to so that lead 16 is laterally displaced to the left side of the main body of breastbone 28 (that is, towards the left side of patient 12 Side).

Defibrillation lead 16 places along breastbone 28 so that defibrillation electrode 18 and second electrode (such as the housing of ICD 14 or Tank 25 or be placed in the electrode on the second lead) between treatment vector substantially across heart 26 ventricle.In an example In, treatment vector can be considered from the line of any a little extending on the housing of ICD 14 or tank 25 defibrillation electrode 18. In another example, defibrillation lead 16 can place along breastbone 28 so that the housing of defibrillation electrode 18 and ICD 14 or tank 25 (or Other electrodes of person) between treatment vector substantially across heart 26 atrium.In this case, the outer icd system 10 of blood vessel Can be used for providing atrial therapy, be such as used for treating the treatment of atrial fibrillation.

Embodiment shown in Fig. 1 is the example constructions of the outer icd system 10 of blood vessel and is not construed as to herein The restriction of described technology.For example although being shown as the center line lateral shift from breastbone 28 in the example of fig. 1, but remove The lead 16 that quivers can be implanted to so that the right of lead 16 sternal 28 offsets or is more centrally disposed to above breastbone 28.Separately Outward, defibrillation lead 16 can be implanted to so that it is not substantially parallel to breastbone 28, but inclined from breastbone 28 with an angle Move (for example, being laterally at an angle of from breastbone 28 in near-end or far-end).As another example, the far-end of defibrillation lead 16 can be determined Position is in patient 12 second or the 3rd near rib.However, depending on the position of ICD 14, electrode 18,20 and 22 position with And other factors, the far-end of defibrillation lead 16 can be positioned in upper or more under.

Although ICD 14 is shown as being implanted near the midaxillary line of patient 12, ICD 14 also can be implanted in patient 12 On other subcutaneous position at, such as towards at posterior axillary line position further below on trunk, towards anterior axillary line on trunk more At position above, in chest area or at the other positions of patient 12.The example implanted by chest in ICD 14 In, lead 16 can follow different paths, for example, across upper breast region and downward along breastbone 28.When ICD 14 is implanted When in chest area, the outer icd system of blood vessel may include the second lead, and this second lead includes defibrillation electrode, this defibrillation electrode Left side along patient extends and makes the defibrillation electrode of the second lead along the left positioner of patient to serve as this icd system The male or female for the treatment of vector.

ICD 14 includes housing or tank 25, and housing or tank 25 form the hermetic seal protecting the part in ICD 14.ICD 14 housing 25 can be formed by conductive material, described conductive material such as titanium or other biological compatibility conductive material or lead Electricity and the combination of non-conducting material.In some instances, the housing 25 of ICD 14 serves as electrode and (is referred to as case electrode or tank electricity Pole), one of it is with electrode 18,20 or 22 is used in combination and is treated to heart 26 with delivering or lived with sensing the electricity of heart 26 Dynamic.ICD 14 may also include connector assembly (sometimes referred to as connector block or head), and this connector assembly includes electric feedthrough component, And include being electrically connected between the electronic unit in housing in the conductor in defibrillation lead 16 by this electric feedthrough component.Housing One or more parts can be sealed, this one or more part include processor, memory, transmitter, receiver, sensor, Sensing circuit, treatment circuit and other appropriate parts (being herein often referenced as module).

Defibrillation lead 16 includes thering is lead body proximally and distally, and this near-end includes being configured to being connected with ICD14 Connector, this far-end includes one or more electrodes 18,20 and 22.The lead body of defibrillation lead 16 can be by non-conducting material (bag Include silicones, polyurethane, fluoropolymer, their mixture and other suitable materials) formed, and it is shaped as shape Become one or more inner chambers that one or more conductors extend in it.However, these technology are not limited to such construction.Although removing The lead 16 that quivers is shown as including three electrodes 18,20 and 22, but defibrillation lead 16 may include more or less of electrode.

Defibrillation lead 16 includes the connector from the near-end of defibrillation lead 16 in lead body and extends to electrode 18,20 and 22 one or more elongated electric conductor (not shown).In other words, it is included in or many in the lead body of defibrillation lead 16 Each of individual elongated electric conductor can engage (engage) with the respective electrode in electrode 18,20 and 22.When defibrillation lead 16 The connector of proximal end when being connected to ICD 14, corresponding conductor (can include associated feedthrough via connector assembly Part) in connection be electrically coupled to the circuit (such as treatment module or sensing module) of ICD 14.These electric conductors will be from ICD The treatment of the treatment module in 14 is sent to one or more of electrode 18,20 and 22, and self-electrode in future 18,20 and 22 One or more of the electric signal being sensed be sent to the sensing module in ICD 14.

ICD 14 can be via the electrical activity of one or more sensing vector sensing hearts 26, this one or more sensing vector Including electrode 20 and 22 and ICD 14 housing or the combination of tank 25.For example, ICD 14 can obtain using electrode 20 and 22 it Between the sensing electric signal that senses of vector, obtain using the sensing between the conductive shell of electrode 20 and ICD 14 or tank 25 to Measure the electric signal that senses, obtain and sensed using the sensing vector between the conductive shell of electrode 22 and ICD 14 or tank 25 Electric signal, or obtain the electric signal sensing using a combination thereof.In some instances, ICD 14 can use and include defibrillation electrode 18 sensing vector (such as between one of defibrillation electrode 18 and electrode 20 or 22 sensing vector or in defibrillation electrode Sensing vector between 18 and ICD 14 housing or tank 25) sensing cardiac electric signals.

ICD can analyze the electric signal sensing to detect tachycardia (such as Ventricular Tachycardia or ventricular fibrillation), and And can produce and deliver electricity treatment to heart 26 in response to tachycardia is detected.For example, ICD 14 can draw via including defibrillation The treatment vector of the defibrillation electrode 18 of line 16 and housing or tank 25 delivers one or more defibrillation shock.Defibrillation electrode 18 can example Elongate coil electrode or other kinds of electrode in this way.In some instances, ICD 14 can before the delivery of defibrillation shock or Pace after delivering one or more pacing therapies, such as anti-tachyarrhythmia pacemaker (ATP) or electric shock afterwards.In these examples, ICD 14 can produce and deliver via the treatment vector including one of electrode 20 and 22 or both and/or housing or tank 25 Fight pulse.Electrode 20 and 22 may include annular electrode, dome electrode, coil electrode, screw electrode, segmented electrode, orientation electricity Pole or other kinds of electrode or combinations thereof.Electrode 20 and 22 can be the electrode of same type or different types of Although in the example of fig. 1, electrode 20 and 22 both of which are shown as annular electrode to electrode.

Defibrillation lead 16 may additionally include the far-end of lead 16 or the attachment feature 29 towards this far-end.Attachment feature 29 can be ring, link thing or other attachment feature.For example, attachment feature 29 can be by suturing the ring-type being formed Thing.Again for example, attachment feature 29 can be ring, link thing, becket, coating metal or polymer.Attachment feature 29 can It is formed with any shape in the uniform or thickness of change and some shapes of size of change.Attachment feature 29 Can be integral with lead or can be added by user before implantation.Attachment feature 29 to help lead 16 implantation and/or It can be useful that lead 16 is fixed to desired implantation position.In some instances, defibrillation lead 16 may include attached spy Fixed mechanism that is outside levying or replacing attachment feature.Although defibrillation lead 16 is shown having attachment feature 29, at other In example, lead 16 can not include attachment feature 29.

(for example, lead 16 may additionally include the connector of the proximal end of lead 16, such as DF4 connector, bifurcation connector DF-1/IS-1 connector) or other kinds of connector.Connector in the proximal end of lead 16 may include and in ICD The terminal pins of the port coupling in 14 connector assembly.In some instances, lead 16 may include the near-end in lead 16 The attachment feature at place, this attachment feature can be coupled to implanting instrument to help the implantation of lead 16.In the proximal end of lead Attachment feature can be separated with connector and can be added by user integral with lead or before implantation.

Defibrillation lead 16 may also include positioned at electrode 22 nearside be configured to lead 16 is fixed on xiphoid-process or lower breastbone Suture set near position or other fixed mechanism (not shown).This fixed mechanism (for example, suture set or other mechanisms) can be with Lead is integral or can be added by user before implantation.

Example shown in Fig. 1 is exemplary in nature, and is not construed as to described in the disclosure Technology restriction.For example, the outer defibrillating system 10 of blood vessel may include the lead of more than one.In one example, blood vessel Outer defibrillating system 10 may include the pacing leads outside defibrillation lead 16.

In FIG in shown example, defibrillation lead 16 is implanted subcutaneously, there was for example between skin and rib or breastbone. In other instances, defibrillation lead 16 (and/or optional pacing leads) can be implanted at other blood vessel external positions.One In individual example, defibrillation lead 16 can be implanted in position under breastbone at least in part.In such configuration, defibrillation lead 16 is extremely A few part can be placed in mediastinum and specifically in the following of the breastbone in anterior mediastinum or lower section.Anterior mediastinum is by chest Film defines, is defined from behind by pericardium and by breastbone 28 from above defining from side.Defibrillation lead 16 can be at least part of Be implanted in other pericardium external positions (that is, around but be not directly contacted with heart 26 outer surface region in position) in.This Other pericardium external positions may include in mediastinum but offset from breastbone 28, in upper mediastinum, in middle mediastinum, in posterior mediastinum a bit In, under xiphoid-process or in lower xiphoid-process region, near the top of heart or be not directly contacted with heart 26 and be not subcutaneous its His position.In further example, lead can be implanted at pericardium position or external membrane of heart position outside heart 26.

Fig. 2 is the exemplary of the electronic circuit in the housing of hermetic seal of subcutaneous according to an embodiment of the invention equipment Schematic diagram.As shown in Figure 2, subcutaneous equipment 14 includes the A-battery 153 coupled to power supply (not shown), and described power supply is with this Mode known to field is the circuit of subcutaneous equipment 14 and powers for supplying the pace-making output capacitor of pacing energy.For example, A-battery 153 can be by one or two conventional LiCF_x、LiMnO₂Or LiI₂Battery is formed.Subcutaneous equipment 14 also includes high pressure Battery 112, described high-tension battery can be by one or two conventional LiSVO or LiMnO₂Battery is formed.Although figure 2 illustrates A-battery and high-tension battery, but according to embodiments of the invention, equipment 14 can be using for high-low pressure purposes Both single batteries.

With further reference to Fig. 2, the function of subcutaneous equipment 14 to control by software, firmware and hardware, described software, firmware Collaboratively monitor ECG signal with hardware, determine when that cardioversion-defibrillation shock or pace-making are necessary, and deliver rule Fixed cardioversion-defibrillation and pacing therapy.Subcutaneous equipment 14 is incorporated into the commonly assigned U.S. of kemel (Keimel) Patent No.5,163,427 " Apparatus for Delivering Single and Multiple Cardioversion And Defibrillation Pulses (for delivering the device of single and multiple cardioversions and defibrillation pulse) " and No.5, 188,105 " Apparatus and Method for Treating a Tachyarrhythmia is (for treating the rapidity heart Restrain not normal apparatus and method) " in the circuit that illustrates for typically with the COMMON output with high-voltage output circuit 140 The ICD IPG case electrode 28 of (share output) 123 coupling and backward and hypodermically setting and with high-voltage output circuit 140 Cardioversion-the defibrillation electrode 24 of HVI output 113 coupling optionally to deliver single-phase, two-phase and continuous two-phase simultaneously the heart Dirty conversion-defibrillation shock.

The charging voltage of the energy of cardioversion-defibrillation shock and capacitor can be between being connect with heart by having at least one The tactile ICD of cardioversion-defibrillation electrode is supplied with the most AED with the cardioversion-defibrillation electrode being contacted with skin The centre of those answered.The use of maximum voltage typical necessary to the ICD of most of biphasic waveforms is about 750 volts, wherein, phase The ceiling capacity of association is about 40 joules.Necessary to AED, typical maximum voltage is about 2000-5000 volt, wherein, is associated Ceiling capacity be about 200-360 joule, be specifically dependent upon used model and waveform.The subcutaneous equipment 14 of the present invention uses Maximum voltage in about 300 to about 1500 volt range and being associated with about 25 to 150 joules or higher of energy.Total high pressure The scope of electric capacity can from about 50 to about 300 microfarads.Only when remote by being processed using detection algorithm as described below Heart ECG and just deliver this cardioversion-defibrillation electricity when pernicious tachyarrhythmia (for example, ventricular fibrillation) is detected Hit.

In fig. 2, the sensing amplifier 190 being combined with pacemaker/equipment timing circuit 178 processes far field ECG sensing letter Number or optionally, virtual signal (that is, two vectorial mathematical combination) (if select if), described sensing signal is across by skin Defined in selected a pair of the tank of bottom electrode 18,20,22 and equipment 14 or housing 25, specific ECG senses vector to produce. For example, equipment can produce such as United States Patent (USP) No.6 in Lee et al., 505,067 " System and Method for Institute in Deriving Virtual ECG or EGM Signal (system and method for deriving virtual ECG or EGM signal) " The Virtual vector signal of description；This patent is incorporated by reference in its entirety.In addition, vector selects to be selected by the doctor of patient Select and be programmed via the telemetry link from programmable device.

Cubicle switchboard is passed through in the selection of sensing electrode pair in the way of providing the most reliable sensing to ECG signal interested Carrying out, described ECG signal interested can be it is believed that being in the ventricular fibrillation leading to die suddenly to battle array/multiplexer (MUX) 191 Risk in patient R ripple.Far field ECG signal reaches the input of sensing amplifier 190, sense through switch matrix/MUX 191 Amplifier 190 comes together to assess the ECG sensing together with pacemaker/equipment timing circuit 178.Bradycardia or heartbeat stop Generally win (escape) interval timer by the ease in pacemaker timing circuit 178 and/or control circuit 144 to determine.When even When the phase exceedes escape interval between continuous R ripple, apply pace-making triggering to the pacing pulse generator 192 producing pacing stimulation Signal.Generally temporarily provide bradycardia pace-making may result in heart slowly to beat when heart is restored back to normal function in delivery Cardioversion-defibrillation shock after maintain cardiac output.Can pass through such as Lee's et al. and be incorporated by reference in its entirety " (noise for monitoring ECG presses down Noise Rejection for Monitoring ECGs United States Patent (USP) No.6,236,882 System) " described in suitable suppression and expansible regulating cycle using sensing subcutaneous far-field signal when assisting and there is noise.

Export from pacemaker/equipment timing 178 and sense amplifier 190 in (as a function of) because becoming Between between the R ripple sensed event signal of timing and control circuits 144, the phase determines the pernicious rapidity rhythm of the heart in control circuit 144 Not normal detection.It should be noted that the present invention, not merely with the signal analysis method based on a phase, also utilizes as will be explained below Supplementary sensor and Morphological scale-space method and apparatus.

Can be contributed to applying using the supplementary sensor of tissue color, tissue oxygenation, breathing, patient activity etc. Or stop the decision-making of defibrillation therapy, and such as Alt's and United States Patent (USP) No.5 that is incorporated by reference in its entirety, 464,434 " Medical Interventional Device Responsive to Sudden Hemodynamic Change (in response to Suddenly the medical intervening equipment of hemodynamics variation) " in be generally described.Sensor process block 194 is via data/address bus 146 provide sensor data to microprocessor 142.Specifically, the activity of patient and/or posture can be by such as existing Sheldon's and United States Patent (USP) No.5,593,431 " the Medical Service that is incorporated by reference in its entirety Employing Multiple DC Accelerometers for Patient Activity and Posture Sensing Retouched in and Method (medical services for the multiple DC accelerometers of application of patient activity and posture sensing and method) " The apparatus and method stated are determining.The breathing of patient can be passed through such as Plicchi's et al. and be incorporated by reference in its entirety United States Patent (USP) No.4,567,892 " Implantable Cardiac Pacemaker (Implanted cardiac pacemaker) " in retouched The apparatus and method stated are determining.The tissue oxygenation of patient or tissue color can be by as Erickson's et al. and by drawing Determined with the sensor device described in overall United States Patent (USP) No.5,176,137 being hereby incorporated by and method.' 137 patents Lambda sensor can be located in subcutaneous equipment pocket, or be alternatively positioned on lead 18, enable to sensing contact or proximity Tactile tissue oxygenation or tissue color.

Executory some steps of collaboratively perform detection algorithm standard rules, microcomputer in microcomputer 142 142 include microprocessor, RAM and ROM, associated circuit and stored can be via the common telemetry interface in this area (not shown) is programmed into the examination criteria in RAM.Data and order via bi-directional data/controlling bus 146 in microcomputer Handed between 142 and timing and control circuits 144, pacemaker timing/amplifier circuit 178 and high-voltage output circuit 140 Change.Pacemaker timing/amplifier circuit 178 is clocked with slow clock rate with control circuit 144.Microcomputer 142 is typically Dormancy, but by thing is sensed by each R ripple when receiving downlink telemetry programming instruction or when delivering cardiac pacing pulse The interruption that part produces is waken up and operated by quick clock, to execute any necessary mathematical computations, to execute tachycardia The time by timer in pacemaker/equipment timing circuit 178 be monitored and controlled with fibrillation detection process and with renewal Between the phase.

When pernicious tachycardia is detected, by high voltage charge circuit 164 by high-voltage capacitor 156,158,160 and 162 voltage levels charging to pre-programmed.It has been generally acknowledged that maintaining the constant electricity on High voltage output capacitor 156,158,160,162 Lotus is inefficient.On the contrary, when control circuit 144 is emitted in the high-voltage charging being delivered to high voltage charge circuit 164 on circuit 145 Start to charge up during order HVCHG, and the feedback signal by double-direction control/data/address bus 166 with from HV output circuit 140 VCAP is controlling charging.High voltage output capacitor 156,158,160 and 162 can be film, aluminium electroloysis or wet tantalum construction.

The negative terminal of high-tension battery 112 couples directly to system earth.On-off circuit 114 normally opened so that high-tension battery 112 positive terminal disconnects the connection with the positive supply input of high voltage charge circuit 164.High-voltage charging order HVCHG also via Conductor 149 conducts to the control input of on-off circuit 114, and on-off circuit 114 is in response to by positive high voltage cell voltage EXT B + connect to high voltage charge circuit 164 positive supply input and close.On-off circuit 114 can be, for example, field-effect transistor And its source electrode has interrupted EXT B+ conductor 118 and its grid to drain path and received the HVCHG signal on conductor 145 (FET). High voltage charge circuit 164 is thereby made to be ready to start with the charging current from high-tension battery 112 to High voltage output capacitor 156th, 158,160 and 162 charging.

High voltage output capacitor 156,158,160 and 162 can be charged to very high voltage, for example, 300-1,500V, With by the body between subcutaneous cardioversion-defibrillation electrode 113 and 123 electrode pair and heart electric discharge.For practice originally Invention, the details of voltage charging circuit is also not to be taken as key；A kind of believe that the high pressure being suitable for the purpose of the present invention fills Circuit is disclosed.High-voltage capacitor 156,158,160 and 162 can for example pass through such as commonly assigned in Wielders et al. " Energy Converter for Implantable Cardioverter is (for implanted for United States Patent (USP) No.4,548,209 The energy converter of cardiovertor) " in high voltage charge circuit 164 described in detail and high frequency high voltage transformer 168 carry out Charge.Suitable charging polarity passes through to interconnect the output winding of high-tension transformer 168 with capacitor 156,158,160 and 162 Diode 170,172,174 and 176 maintaining.As described above, the state of condenser charge is by high-voltage output circuit 140 Monitoring, the VCAP feedback signal of instructed voltage is supplied to timing and control circuits 144 to circuit by high-voltage output circuit 140.When During VCAP Signal Matching capacitor output voltage by programming (that is, cardioversion-defibrillation peak value shock voltage), timing and control Circuit 144 terminates high-voltage charging order HVCHG.

Then, control circuit 144 produces the first and second control signals NPULSE 1 and NPULSE 2, the first and the respectively Two control signals NPULSE 1 and NPULSE 2 are applied to high-voltage output circuit 140 for triggering cardioversion or defibrillation electricity The delivery hit.Especially, the triggering of NPULSE 1 signal includes the electric discharge of the first capacitor bank of capacitor 156 and 158.NPULSE 2 signals trigger the first capacitor bank and include the electric discharge of the second capacitor bank of capacitor 160 and 162.Can simply lead to Cross modification NPULSE 1 and the quantity asserted of NPULSE 2 signal and time sequencing is come in multiple output pulse condition (pulse Regime select between).NPULSE 1 signal and NPULSE 2 signal can sequentially, simultaneously or be provided separately.With this Mode, control circuit 144 is used for controlling the operation of High voltage output level 140, and High voltage output level 140 is coupled to as shown in Figure 2 Cardioversion-the defibrillation electrode of HV-1 output and COMMON output (sharing output) is multiple to delivering high-energy cardiac between 18 and 25 Rule-defibrillation shock.

Therefore, subcutaneous equipment 14 is monitored the heart state of patient and is needed the fast of cardioversion-defibrillation in response to detecting Speed arrhythmia cordis and pass through cardioversion-defibrillation electrode 18 and 25 initiate cardioversion-defibrillation shock delivery.High HVCHG Signal so that high-tension battery 112 is connected with high voltage charge circuit 164 by on-off circuit 114 and start to output capacitor 156, 158th, 160 and 162 charging.Charging is continued until and reflects charging voltage by programming by VCAP signal, now controls and fixed When circuit 144 HVCHG signal is set to low, thus terminating charging and open on-off circuit 114.Subcutaneous equipment 14 can be programmed Become to attempt in timing synchronization cardioversion shock to be delivered to heart with the R ripple detecting in the above described manner, or can be programmed Or be manufactured into do not attempt making described deliver and the R ripple synchronization detecting in the case of in the above described manner defibrillation shock is delivered to Heart.The event data that the delivery of the detection to tachyarrhythmia and cardioversion-defibrillation shock is related can be stored in It is transferred to external programmer well known in the art for up-link remote measurement thus helping the heart to patient in RAM The diagnosis of state.Based on prevention, the patient of receiving device 14 can be instructed to report each this event to enter one to the doctor in charge Step is assessed the situation of patient and is evaluated to the needs implanting more complicated ICD.

Subcutaneous equipment 14 Desirably includes telemetric circuit (not shown in Fig. 2) so that it can be via bidirectioanl-telemetry Link (not shown) is programmed by external programmer 20.Up-link remote measurement allows equipment state and diagnosis/event data It is sent to external programmer 20 and consult for the doctor of patient.Downlink telemetry controls permission external programmer energy via doctor The optimization of enough detections to functions of the equipments and for particular patient and treatment is programmed.It is suitable for the practice in the present invention Used in programmable device and telemetry system well known for many years.Known programmable device generally via bi-directional RF telemetry link with The equipment communication implanted so that programmable device can send the control command intending being received by the equipment implanted and operational parameter value, So that the equipment implanted can send diagnostic data and peration data to programmable device.Believe the mesh being suitable for putting into practice the present invention Programmable device include can be commercially available from Medtronic Inc. (Medtronic, Inc.) of Minneapolis, Minnesota Models 9790 HeProgrammable device.

For providing multiple remote measurement systems of the necessary communication channel between external programmer unit and the equipment implanted System has been developed that and is well known in the art.Believe that the telemetry system being suitable for putting into practice the purpose of the present invention is disclosed In for example following United States Patent (USP)：Entitled " the Telemetry Format for Implanted Medical of Wyborny et al. United States Patent (USP) No.5,127,404 of Device (for the remote mode of the Medical Devices of implantation) "；Markowitz's is entitled " the Marker Channel Telemetry System for a Medical Device (marked channels for Medical Devices Telemetry system) " United States Patent (USP) No.4,374,382；And entitled " the Telemetry System for of Thompson et al. United States Patent (USP) No.4,556,063 of a Medical Device (for the telemetry system of Medical Devices) ".Wyborny et al. ' 404, Markowitz ' the patent of 382 and Thompson et al. ' 063 is commonly assigned to assignee of the present invention, and Each here is incorporated by reference in its entirety.

According to embodiments of the invention, in order to automatically select preferred ECG vector set, there is the credit rating of evaluation signal Quality factor be necessary." quality " is defined as the room property rapidity heart of the usual sinus rhythm in patient for the signal and patient Accurate heart rate is provided to estimate between rule is not normal and the detached ability of accurate form waveform.

Suitable index may include R wave-amplitude, R crest value amplitude (that is, the noise with respect to the amplitude of wave form between R ripple Than), low slope content, relative high frequency to low frequency power, estimation for mean frequency, probability density function or these tolerance some Combination.

Can in implantation or periodically (daily, weekly, monthly) or both carry out with having concurrently selecting from moving vector.Planting Enter at thing, select to start, described automatic equipment opening program as a part for automatic equipment opening program from moving vector Execute sort of activity when measuring lead impedance and cell voltage.Opening of device program can be started by implantation doctor and (for example, pass through Press programmable device button), or alternatively can in the automatic detection of equipment/lead implantation automatic.By subcutaneous equipment 14 In position and before closing otch, opening program it is also possible to use to determine ECG from moving vector selection standard for equipment suture Vectorial quality is if appropriate for current patents and if appropriate for equipment and wire locations.This ECG quality index will allow implantation Equipment is transferred to new position or orientation to improve the quality of ECG signal by doctor as needed.Also can be as setting at implant Standby opening program a part of selecting preferably one or more ECG vectors.Preferably vector can be to have to make heart rate estimate Those vectors of meter and the detection maximized index of accuracy.Also there may be by doctor's preferred priori vector set, as long as and Those vectors exceed certain minimum threshold, or be simply slightly worse than some other more it is desirable that vector, just select the excellent of priori Choosing vector.Some vectors can be considered as almost identical so that they are without being tested, unless priori selected to Figureofmerit falls below a certain predetermined threshold.

Tolerance power consumption according to equipment and power demand, can be frequent on demand in vector (or alternately, subset) scope Measurement ECG signal quality metric.Can for example per minute, per hour, daily, weekly or monthly on the basis of data is received Collection.Frequent measurement (for example, per minute) can As time goes on be averaged and for based on vector to for example making an uproar once in a while The susceptibility of sound, motion artifacts or EMI is selecting vector.

Alternatively, subcutaneous equipment 14 can have indicator/sensor (pressure resistance type, accelerometer, the impedance of patient activity Deng) and in moderate or height patient activity's phase to the most as little as postponing automatic vector measurement during the non-activity phase.A kind of representative Scheme may include and daily or weekly falls asleep (using internal clock (for example, 2 having determined patient:00am), or alternatively by Determine patient position (via 2 axles or 3 axis accelerometers) and activity shortage to infer sleep) when carry out once to ECG to Test/the assessment of amount.In another feasible program, can daily or weekly execute once to ECG when learning that patient takes exercise Measurement/the assessment of vector.

Noise (for example, muscle, motion, EMI if carrying out automatic, periodic measurement infrequently, in measurement signal Deng) and postpone vector to select the time period that measurement has been disappeared up to noise to be also desirable.

Subcutaneous equipment 14 optionally has the indicator (via 2 axles or 3 axis accelerometers) of the posture of patient.This biography Sensor can be used for guaranteeing that the qualitative difference of ECG is simply not the result changing posture/position.This sensor can be used for receiving Data during the many postures of collection makes ECG mass can be averaged in these postures or otherwise combines or alternatively Selected for preferred posture.

In one embodiment, can by clinician in implantation or to the further consultation of clinic during or via equipment and The remote link of programmable device is remotely executed vectorial quality metric and calculates using programmable device.According to another embodiment, can be directed to Each can with sensing vector by equipment come with pre-determined number, so multiple daily, automatically hold once a day, weekly or by the month Row vector quality metric calculates.In addition, can be averaging to these values for each vector during such as one week.It is averaging Can be made up of rolling average or recursive average, be specifically dependent upon time weight and the consideration of memory.

Fig. 3 be according to an embodiment in Medical Devices sensing vector selection course in along multiple sense to The figure measuring the heart signal sensing represents.As shown in Figure 3, during vectorial selection course, this equipment uses this area The known sensing skill being such as documented in such as U.S. Patent application No.14/250,040 (being incorporated by reference in its entirety) Art is directed to each available sensing vector sensing heart signal, and the result based on the signal sensing is to described available sensing Vector carries out ranking and determines one or more desired sensing vectors based on the ranking of the obtained vectorial 102-106 of sensing. For example, as shown in Figure 3, according to an embodiment, this equipment is from each of available sensing vector sensing ECG signal 100, the level that described available sensing vector includes extending between housing or tank 25 and electrode 22 senses vector 102, in shell The diagonal sensing vector 104 extending between body or tank 25 and electrode 20 and the vertical sense extending between electrode 20 and 22 Direction finding amount 106.This equipment determines the R ripple 108 sensing for the vectorial 102-106 of each sensing, and described R ripple 108 is in sense That the signal over-time measuring relies on, self-adjusting sensing occurs during threshold value 110.

Once R ripple 108 is sensed, this equipment is just based on sensing for each of the vectorial 102-106 of sensing R ripple 108 arranging vectorial quality metric detection window 112, for determining the vectorial matter being associated with sensing vector 102-106 Metric.According to embodiment, this equipment setting quality metric detection window 112 is to be located at from R ripple 108 preset distance 116 and to have Start at the starting point 114 having detection window width 118 to allow to execute dividing to signal 100 in the desired extent of signal 100 Analysis, is likely to the T ripple of the QRS signal that appearance is associated with the R ripple 108 sensing in this desired extent.For example, this equipment is by matter Metric detects that window 112 is set to the width 118 with about 200 milliseconds, and wherein quality metric detects the starting point 114 of window 112 In between the R ripple 108 about 150-180 millisecond sensing, and width 118 from detection window starting point 114 to detection window terminal 120 (that is, at a distance from the R ripple 108 about 350-380 millisecond detecting) extends such as 200 milliseconds.According to another embodiment, wide Degree 118 from detection window starting point 114 to detection window terminal 120 (that is, from the R ripple 108 about 420-450 millisecond detecting away from From place) extend such as 270 milliseconds.Once quality metric detection window 112 is set, this equipment just determines quality metric detection window The minimum signal between the signal 100 sensing and sensing threshold value 110 in 112 differs from 122, that is, in the signal 100 sensing The minimum range extending and sensing threshold value 110 between, as described below.

Fig. 4 is the flow chart according to exemplary embodiment for selecting the method for one or more sensing vectors.As Fig. 3 Shown in 4, sense, for from corresponding, each heart signal 100 that vectorial 102-106 obtains, this equipment obtains heart signal The 100 R ripple 108 (frame 200) sensing, and arranged based on the R ripple 108 sensing for this sensing vector 102-106 Quality metric detection window 112 (frame 202).Once quality metric detection window 112 is positioned, this equipment is just directed in sensing vector Each come to determine quality metric detect window 112 in the heart signal 100 sensing and sensing threshold value 110 between minimum Signal difference 122 (frame 204).Determined by minimum signal differ from 122 and stored, and this equipment determines whether to have been for sensing vector For predetermined threshold number, each of 102-106 determines that minimum signal differs from 122 (frames 206) cardiac cycle.If be not directed to The vectorial 102-106 of each sensing be predetermined threshold number determine minimum signal poor (no in frame 206) cardiac cycle, then this sets Obtain next R ripple 108 for for the vectorial 102-106 of each sensing, and be directed to each of vectorial 102-106 of sensing and be The cardiac cycle that the next one senses repeats this process.According to an embodiment, for determining minimum letter such as 15 cardiac cycle Number differ from 122.

Once be predetermined threshold number cardiac cycle in determine that minimum signal differs from 122 (frames 206 all cardiac cycles In be), this equipment just determines the vectorial selected metric of each vectorial 102-106, this determination be based on determined for this vector 15 minimum signals differ from 122 (frames 208).For example, according to embodiment, this equipment is directed to each sensing vector and determines 15 minimums The vectorial selected metric of this sensing vector is simultaneously equal to associated minimum signal and differs from 122 by the intermediate value of signal difference 122 Determined by intermediate value.Once being directed to each of vectorial 102-106 of sensing in frame 208 to determine single vector-quantities selected metric, This equipment just carries out ranking (frame 210) to the vectorial selected metric of sensing vector 102-106.For example, this equipment is from up to Low to determined by vectorial selected metric carry out ranking so that in the example of fig. 3, diagonal sensing vector 104 will be ranked In highest, because being 0.84 millivolt for this vectorial intermediate value minimum signal difference, level sensing vector 102 is by ranked the Two because being 0.82 millivolt for this vectorial intermediate value minimum signal difference, and vertical sensing measurement vector 106 by ranked the 3rd, Because the intermediate value minimum signal difference for this sensing vector is 0.55 millivolt.

Once having carried out ranking to sensing vector in block 210, this equipment just selects to stay in follow-up sensing and the heart By sensing vector (frame 212) of this equipment utilization during the not normal detection of rule.Depend on being programmed to 102- vectorial in sensing The time quantum existing between 106 renewal, i.e. when for example little, day, week or the moon, this equipment waits until the scheduled time next time (scheduled) vector select determine (frame 214), repeat vectorial selection course at that time.

Fig. 5 is the flow chart according to another exemplary embodiment for selecting the method for one or more sensing vectors. As shown in figs. 3 and 5, according to another embodiment, sense, for from corresponding, each heart signal that vectorial 102-106 obtains 100, this equipment obtains the R ripple 108 (frame 300) sensing of heart signal 100, and based on for this sensing vector 102-106 The R ripple 108 sensing to arrange quality metric detection window 112 (frame 302), as mentioned above.Once quality metric detects window 112 It is positioned, this equipment is just directed to each of vectorial 102-106 of sensing to determine sensing in quality metric detection window 112 To heart signal 100 and sensing threshold value 110 between minimum signal differ from 122 (frames 304).Determined by minimum signal differ from 122 Stored, and this equipment to determine whether to have been for the cardiac cycle that the vectorial 102-106 of each sensing is predetermined threshold number true Determine minimum signal and differ from 122 (frames 306), i.e. such as, such as 15 cardiac cycle.

If be not directed to the vectorial 102-106 of each sensing be number of thresholds determine that minimum signal differs from 122 (frames cardiac cycle No in 306), then this equipment determines whether predetermined timer has expired (frame 308).If timer not yet expires (in frame 308 No), then this equipment is directed to the vectorial 102-106 of each sensing and obtains next R ripple 108, and for the vectorial 102-106 of sensing Each of for the next one sense repeat this process cardiac cycle.According to an embodiment, the timer quilt in frame 308 It is set to such as 40 seconds.

In some instances, this equipment may can not obtain requirement for one or more of sensing vector Minimum signal differ from 122, therefore, if timer has expired (being in frame 308), this equipment determine whether for sensing to In amount 102-106 at least two obtain the minimum signal poor (frame 314) of requirement.If be not directed in sensing vector The minimum signal of at least two acquisition requirements is poor, i.e. also do not have for the only one in the vectorial 102-106 of sensing or one There is (no in frame 314), then this equipment determines that not sensing vector selects can carry out (frame 310), and depends on being programmed to The time quantum existing between the renewal of the vectorial 102-106 of sensing, i.e. when for example little, day, week or the moon, this equipment waits until The vector of the scheduled time selects to determine (frame 312) next time, repeats vectorial selection course at that time.

If the minimum signal obtaining requirement at least two in the vectorial 102-106 of sensing is poor (in frame 314 Be), then this equipment select in a block 320 this two sensing vector with during follow-up sensing and arrhythmia detection By this equipment utilization.As described above, depending on the time quantum being programmed to presence between the renewal of the vectorial 102-106 of sensing, That is, for example when little, day, week or the moon, this equipment waits until that the vector of the scheduled time next time selects to determine (frame 312), then Repeat vectorial selection course at that time.

Differ from 122 (frames as having been for the minimum signal that determines cardiac cycle that the vectorial 102-106 of each sensing is predetermined quantity In 306 it is), then this equipment determines the vectorial selected metric of each vectorial 102-106, and this determination is based on true for this vector institute 15 fixed minimum signals differ from 122 (frames 316).For example, according to embodiment, this equipment is directed to each sensing vector and determines 15 The vectorial selected metric of this sensing vector is simultaneously equal to associated minimum signal and differs from 122 by the intermediate value of primary differential signal 122 Determined by intermediate value.Once being directed to each of vectorial 102-106 of sensing in frame 316 to determine single vector-quantities selectance Amount, this equipment just carries out ranking (frame 318) to the vectorial selected metric of sensing vector 102-106.For example, this equipment is from up to Minimum to determined by vectorial selected metric carry out ranking so that in the example of fig. 3, diagonal sensing vector 104 will be arranged , in highest, because being 0.84 millivolt for this vectorial intermediate value minimum signal difference, level sensing vectorial 102 is by ranked for name Two because being 0.82 millivolt for this vectorial intermediate value minimum signal difference, and vertical sensing measurement vector 106 by ranked the 3rd, Because the intermediate value minimum signal difference for this sensing vector is 0.55 millivolt.

Once having carried out ranking to sensing vector in frame 318, this equipment just selects to stay in follow-up sensing and the heart By sensing vector (frame 320) of this equipment utilization during the not normal detection of rule.According to another embodiment, can be in such as programmable device The result of upper display ranking enables the user to select sensing vector.Depend on being programmed to the vectorial 102-106's of sensing The time quantum existing between renewal, i.e. when for example little, day, week or the moon, this equipment waits until the vector of the scheduled time next time Select to determine (frame 312), repeat vectorial selection course at that time.In addition, according to another embodiment, user can manually boot to Amount selection course receives user's input so that this equipment will wait until, and will repeat the next scheduled time at that time Vectorial selection course.

Fig. 6 is the flow chart according to another exemplary embodiment for selecting the method for one or more sensing vectors. As described above, in some instances, this equipment may can not obtain requisite number for one or more of sensing vector The minimum signal of amount differs from 122.In addition, when ECG signal is more than or equal in one or more cardiac cycles or whole quality degree During sensing threshold value in amount sensing window 112, there may be in one or more of vectorial 102-106 of sensing for cardiac cycle One or more of minimum signal differ from 122 null situations.The such situation of zero minimum signal difference may reflect T ripple mistake Sensing or the contraction of frequent room property or high heart rate sense (more than 150 heartbeats per minute) or occur in making an uproar in sensing vector Sound.

Therefore, according to an embodiment, as shown in figures 3 and 6, sense what vectorial 102-106 obtained for from corresponding Each heart signal 100, this equipment obtains the R ripple 108 (frame 400) sensing of heart signal 100, and based on for this sensing The R ripple 108 sensing of vectorial 102-106 come to arrange quality metric detection window 112 (frame 402), as mentioned above.Once quality degree Amount detection window 112 is positioned, and this equipment is just directed to each of vectorial 102-106 of sensing to determine quality metric detection window The minimum signal between the heart signal 100 sensing and sensing threshold value 110 in 112 differs from 122 (frames 404).In addition, this sets Determine whether the generation (frame 416) during detection window 112 of zero minimum signal difference for for the vectorial 102-106 of each sensing.If There is (being in frame 416) in zero minimum signal difference during detection window 112, then abandon the R ripple (frame with this vector correlation connection 418), and to whether timer has expired it is determined, as described below.

If zero minimum signal difference does not occur (no in frame 416) during detection window 112, this equipment determines whether Be predetermined threshold number determine that minimum signal differs from 122 (frames 406) cardiac cycle, i.e. such as, such as 15 cardiac cycle. If be not directed to the vectorial 102-106 of each sensing be number of thresholds determine that minimum signal differs from 122 (in frame 406 cardiac cycle No), then this equipment determines whether predetermined timer has expired (frame 408).If timer not yet expires (no in frame 408), Then this equipment is directed to the vectorial 102-106 of each sensing and obtains next R ripple 108, and for every in the vectorial 102-106 of sensing One is repeated this process cardiac cycle for what the next one sensed.According to an embodiment, the timer in frame 408 is arranged to Such as 40 seconds.

If timer has expired (being in frame 408), this equipment determines whether in the vectorial 102-106 of sensing At least two minimum signals poor (frame 414) obtaining requirement.If at least two acquisitions not being directed in sensing vector The minimum signal of requirement is poor, i.e. for the only one in the vectorial 102-106 of sensing or no one (in frame 414 No), then this equipment determines that not sensing vector selects can carry out (frame 410), and depends on being programmed in sensing vector The time quantum existing between the renewal of 102-106, i.e. when for example little, day, week or the moon, this equipment waits until and makes a reservation for next time The vector of time selects to determine (frame 412), repeats vectorial selection course at that time.

If the minimum signal obtaining requirement at least two in the vectorial 102-106 of sensing is poor (in frame 414 Be), then this equipment select in a block 320 this two sensing vector with during follow-up sensing and arrhythmia detection By this equipment utilization.As described above, depending on the time quantum being programmed to presence between the renewal of the vectorial 102-106 of sensing, That is, for example when little, day, week or the moon, this equipment waits until that the vector of the scheduled time next time selects to determine (frame 412), then Repeat vectorial selection course at that time.

Differ from 122 (frames as having been for the minimum signal that determines cardiac cycle that the vectorial 102-106 of each sensing is number of thresholds In 406 it is), then this equipment determines the vectorial selected metric of each vectorial 102-106, and this determination is based on true for this vector institute 15 fixed minimum signals differ from 122 (frames 420).For example, according to embodiment, this equipment is directed to each sensing vector and determines 15 The vectorial selected metric of this sensing vector is simultaneously equal to associated minimum signal and differs from 122 by the intermediate value of primary differential signal 122 Determined by intermediate value.Once being directed to each of vectorial 102-106 of sensing in frame 420 to determine single vector-quantities selectance Amount, this equipment just carries out ranking (frame 422) to the vectorial selected metric of sensing vector 102-106.For example, this equipment is from up to Minimum to determined by vectorial selected metric carry out ranking so that in the example of fig. 3, diagonal sensing vector 104 will be arranged , in highest, because being 0.84 millivolt for this vectorial intermediate value minimum signal difference, level sensing vectorial 102 is by ranked for name Two because being 0.82 millivolt for this vectorial intermediate value minimum signal difference, and vertical sensing measurement vector 106 by ranked the 3rd, Because the intermediate value minimum signal difference for this sensing vector is 0.55 millivolt.

Fig. 7 be according to another embodiment in Medical Devices sensing vector selection course in along multiple sense to The figure of the heart signal of amount sensing represents.As shown in Figure 7, during vectorial selection course, this equipment is directed to available sensing One or more of vector senses heart signal 500, as mentioned above.When signal 500 over-time is relying on, self-adjusting sense When surveying threshold value 510, R ripple 508 is sensed.Once R ripple 508 is sensed, this equipment is just based on 102-106 vectorial for sensing Each of the R ripple 508 sensing arranging predetermined blanking interval 509 and quality metric window 512, for determining and sensing The vectorial quality metric that vectorial 102-106 is associated.According to an embodiment, blanking interval 509 is set to from sensing this equipment To R ripple 508 start to extend predetermined amount of time extend to blanking interval terminal 511.For example, blanking interval 509 can be arranged to 150 Millisecond, but any initial setting up can be used, typically range between 150 and 180 milliseconds.Setting blanking interval adjustment window 513, should Blanking interval adjustment window 513 extends to blanking interval adjustment terminal 514 from blanking interval terminal 511.Blanking interval adjusts the width of window 513 517 current settings that will depend upon blanking interval.Because according to an embodiment, blanking interval is typically provided at 150 and 180 millis Between second, if so blanking interval is 150 milliseconds, blanking interval adjustment window 513 will be 30 milliseconds.In this way, blanking The width 517 that phase adjusts window 513 depends on selected blanking interval scope.

In addition, quality metric window 512 is set on starting from blanking interval adjustment terminal 514 and having detection window by this equipment Width 518, to allow to execute analysis to signal 500 in the expected range of signal 500, in this expected range, and senses The T ripple of QRS signal that is associated of R ripple 508 be likely occurred.For example, quality metric is detected that window 512 is set to have by this equipment There is about 200 milliseconds of width 518, wherein quality metric detects that the starting point 515 of window 512 is located at blanking interval terminal 514 and width Degree 518 is from detection window starting point 515 to detection window terminal 520 (that is, when blanking interval 509 is arranged on 150 milliseconds from detecting The distance of about 350 milliseconds of R ripple 508 at) extend 200 milliseconds.Once blanking interval adjustment window 513 and quality metric detection window 512 Be set, this equipment just determine blanking interval adjust window 513 in the signal 500 sensing and sensing threshold value 510 between The minimum between the signal 500 sensing and sensing threshold value 510 in primary differential signal 519, and quality metric detection window 512 Signal difference 522, as described below.

Fig. 8 is the flow chart according to another exemplary embodiment for selecting the method for one or more sensing vectors. As shown in Fig. 7 and 8, sense, for from corresponding, each heart signal 500 that vectorial 102-106 obtains, this equipment obtains the heart The R ripple 508 (frame 600) sensing of dirty signal 500, and based on the R ripple 508 sensing for this sensing vector 102-106 Blanking interval adjustment window 513 and quality metric detection window 512 (frame 602) are set.Once blanking interval adjustment window 513 and quality metric Detection window 512 is positioned, and this equipment is just directed to each of sensing vector to determine sensing in blanking interval adjustment window 513 To heart signal 500 and sensing threshold value 510 between minimum signal differ from 519 and quality metric detect window 512 in sense Minimum signal between the heart signal 500 measuring and sensing threshold value 510 differs from 522 (frames 604).Determined by minimum signal poor 519 and 522 are stored, and this equipment determines whether that having been for sensing each of vectorial 102-106 is predetermined threshold number That measures determines that minimum signal differs from 519 and 522 (frames 606) cardiac cycle.

If be not directed to the vectorial 102-106 of each sensing be predetermined threshold number determine that minimum signal is poor cardiac cycle 519 and 522 (no in frame 606), then this equipment be directed to the vectorial 102-106 of each sensing and obtain next R ripple 508, and pin Each of 102-106 vectorial to sensing repeats this process cardiac cycle for what the next one sensed.According to an embodiment, Determine that minimum signal differs from 519 and 522 cardiac cycle for such as 15.

Once be predetermined threshold number cardiac cycle in determine that minimum signal differs from 519 and 522 all cardiac cycles (being in frame 606), this equipment just determines the vectorial selected metric of each vectorial 102-106, and this determination is based on for this vector Determined by 15 minimum signals differ from 522 (frames 608).For example, according to embodiment, this equipment is directed to each sensing vector and determines 15 Individual minimum signal differs from 522 intermediate value and that the vectorial selected metric of this sensing vector is equal to associated minimum signal is poor Intermediate value determined by 522.Once being directed to each of vectorial 102-106 of sensing in block 608 to determine that single vector-quantities select Tolerance, this equipment just carries out ranking (frame 610) to the vectorial selected metric of sensing vector 102-106.For example, this equipment is from highest To minimum to determined by vectorial selected metric carry out ranking so that in the example in figure 7, diagonal sensing vector 104 will be by Ranking in highest because being 0.86 millivolt for this vectorial intermediate value minimum signal difference, level sensing vector 102 by ranked Second because being 0.63 millivolt for this vectorial intermediate value minimum signal difference, and vertical sensing measurement vector 106 by ranked the Three, because the intermediate value minimum signal difference for this sensing vector is 0.32 millivolt.

Once having carried out ranking to sensing vector in block 610, this equipment just selects to stay in follow-up sensing and the heart By sensing vector (frame 612) of this equipment utilization during the not normal detection of rule.In addition, this equipment can determine that disappearing of current setting Whether the hidden phase is less than the corresponding predetermined blanking interval threshold value (frame with desired maximum time period (that is, 180 milliseconds as above) 614).Depending on being programmed to the time quantum that exists between the renewal of the vectorial 102-106 of sensing, i.e. when for example little, day, week Or the moon, if current blanking is not less than blanking interval threshold value (no in frame 614), this equipment waits until the scheduled time next time Vector select determine (frame 622), repeat vectorial selection course at that time.

If current blanking is less than blanking interval threshold value (being in frame 614), this equipment differs from 519 based on 15 minimum signals Determine blanking interval adjustment tolerance (frame 616) of each vectorial 102-106.For example, according to embodiment, this equipment is directed to each and senses Vector determines that 15 minimum signals differ from 519 intermediate value and are equal to be associated by the blanking interval adjustment tolerance of this sensing vector Minimum signal differ from intermediate value determined by 519.Once being directed to each of vectorial 102-106 of sensing in block 616 to determine Single blanking interval adjustment tolerance, this equipment just determines whether to carry out the adjustment of blanking period for the vectorial 102-106 of sensing (frame 618).A reason increasing blanking interval is in order to avoid the repeat count to R ripple.According to an embodiment, in order to determine Whether adjust blanking interval from current setting, two top ranked vectors that this equipment is directed to from frame 610 determine corresponding institute The blanking interval adjustment tolerance determining whether less than vectorial selected metric determined by corresponding certain proportion and less than predetermined Minimum blanking interval threshold value.

For example, using Fig. 7 result (in the figure 7, diagonal sensing vector 104 by ranked in highest because be directed to this The intermediate value minimum signal difference of vector is 0.86 millivolt, and level senses vector 102 by ranked second, because being directed to this vector Intermediate value minimum signal difference be 0.63 millivolt), this equipment determine for diagonal sensing vector 104 determined by blanking interval adjustment Whether tolerance had both been less than the half of the vectorial selected metric (that is, 0.86 millivolt) of this sensing vector, again smaller than 0.05 millivolt, and Whether both it had been less than the vectorial selected metric of this sensing vector for blanking interval adjustment tolerance determined by level sensing vector 102 The half of (that is, 0.63 millivolt), again smaller than 0.05 millivolt.

If blanking interval adjustment tolerance is not less than the predetermined ratio of one of two top ranked vectors or not little In predetermined minimum blanking interval threshold value (no in frame 618), then this equipment waits until the vector selection of the next scheduled time Determine (frame 622), repeat vectorial selection course at that time.Depend on being programmed between the renewal of the vectorial 102-106 of sensing The time quantum existing, the renewal of the scheduled time next time of vector can occur within such as one hour, one day, one week or January.

If blanking interval adjustment tolerance is less than the predetermined ratio of one of two top ranked vectors and less than pre- Fixed minimum blanking interval threshold value (being in frame 618), then update blanking interval (frame 620).For example, blanking interval can be added to 180 Millisecond, or predetermined amount (such as 10 milliseconds) can be increased.In addition, according to another embodiment, not being automatically to increase blanking interval, and It is that this equipment can produce alarm or the instruction of other storages to increase blanking interval so that can make to medical worker on the scene instruction Manually adjust the described increase of blanking interval with programmable device or other input equipments.

Fig. 9 is the state diagram of the ARR detection in Medical Devices according to an embodiment of the invention.As institute in Fig. 9 Show, according to embodiment, this equipment is being indifferent to state (Not Concerned State) 702, is being concerned about state (Concerned State) 704, armed state (Armed State) changes between 706 and shock state 708, such as example in Stadler et al. United States Patent (USP) No.7, described in 894,894, this patent is incorporated by reference in its entirety.For example, in routine operation mistake Cheng Zhong, this equipment is in be indifferent in state 702, and during being indifferent to state 702, between R ripple, the phase is estimated to identify soon Fast heart rate phase and/or asystolic appearance.When being detected simultaneously by the phase between short R ripple in the ECG sensing vector separate at two If (being confirmed, indicate that and may need to deliver the event for the treatment of), this equipment is converted to pass heart shaped from being indifferent to state 702 State 704.When being in care state 704, the predetermined window of this equipment evaluation ECG signal, to determine that signal is subject to noise to destroy Possibility and using R ripple between phase and ECG signal shape information combination come distinguish the rhythm of the heart needing peb treatment and those not Need the rhythm of the heart of peb treatment, such as example in the U.S. Patent application No.14/250 of Zhang, in 040 with Stadler et al. United States Patent (USP) No. United States Patent (USP) No.7, described in 894,894, above-mentioned patent application and patent are all by quoting entirety It is hereby incorporated by.

If continuing when being in care state 704 rhythm of the heart needing peb treatment is detected, this equipment is from care State 704 is converted to armed state 706.If no longer detecting when this equipment is in care state 704 needs electric shock to control Between the rhythm of the heart treated and R ripple, the phase is confirmed as being no longer short, then this equipment returns to and is indifferent to state 702.If however, The rhythm of the heart needing peb treatment is no longer detected when this equipment is in care state 704 but between R ripple the phase continue to be detected as Short, then continue to be processed in care state 704.

In armed state 706, this equipment charges in high-voltage electric shock capacitor and continues between monitoring R ripple for spontaneous termination Phase and ECG signal form.If it happens need the spontaneous termination of the rhythm of the heart of peb treatment, then this equipment returns to and is indifferent to state 702.Once if the charging complete of capacitor, needing the rhythm of the heart of peb treatment to be still determined to be in generation, then this equipment is from treating Life state 706 is converted to shock state 708.In shock state 708, this equipment delivers and shocks by electricity and return to armed state 706 To assess the success of delivered treatment.

Figure 10 is the side for adjusting blanking interval during the transformation between mode of operation in accordance with an embodiment of the present disclosure The flow chart of method.As shown in Figure 10, in accordance with an embodiment of the present disclosure, when being in care state 704, this equipment is using such as United States Patent (USP) No. United States Patent (USP) for example in the U.S. Patent application No.14/250,040 of Zhang with Stadler et al. Described in No.7,894,894 for determining that sensing channels are that method that is can shocking by electricity or can not shocking by electricity to determine sensing Whether channel ECG1 and ECG2 is (frame 802) that can shock by electricity, and above-mentioned patent application and patent are all incorporated by reference in its entirety. For example, according to an embodiment, when this equipment is in care state 704, using coming self-channel ECG1's and ECG2 The nearest window of ECG data, such as, such as three seconds so as to trigger process by three seconds time-out in care state 704.Manage Solution be although this process be described as more than three seconds during and be triggered, but also optionally at be concerned about state 304 in when institute The other times section for process time utilizing, but should be preferably in the range of 0.5 to 10 seconds.Result although When in care state 704, the sensing of independent R ripple is all continued to occur in channel ECG1 and ECG2, but from care state 704 change chance to another state only in the just appearance once three seconds timers expire.When initially entering care state 704, Advantageously process the ECG data of nearest three second, i.e. in the ECG number being converted to before care state 704 three seconds According to.This needs the buffering that the ECG data of nearest three seconds is continuously circulated, though be in be indifferent in state 702 when Also it is.

When being in care state 704, this equipment determine the signal in this two sensing channels be how sinusoidal and How noise is to determine ventricular fibrillation (VF) or the fast occurent possibility of Ventricular Tachycardia (VT) event, because signal Sine and low noise, VT/VF event more may occur.Based on this analysis, this equipment is by sensing channels It is categorized as one of to shock by electricity or can not shocking by electricity.According to an embodiment, this equipment can be by channel ECG1 and ECG2 both of which It is identified as can shocking by electricity or can not shocking by electricity, such as in entitled " the Method and Apparatus for of Zhang Discriminating Tachycardia Events in A Medical Device Using Two Sensing Vectors (for the method and apparatus to distinguish tachycardia event in Medical Devices using two sensing vectors) " is total to With the U. S. application No.14/250 transferring the possession of, described in 040, this application is incorporated by reference in its entirety.Based on whether will It is categorized as can shocking by electricity or can not shocking by electricity for currently vectorial sensing channels, whether should be from care state to this equipment 704 are converted to another state is determined (frame 804).

For example, in accordance with an embodiment of the present disclosure, if predetermined quantity (such as, the example for channel ECG1 and ECG2 As in three two) three seconds sections be classified as being and can shock by electricity, then confirm from care state 704 to armed state 706 Transformation.If three of the predetermined quantity in channel ECG1 and ECG2 seconds sections be classified as to shock by electricity (in frame 804 It is), then this equipment is converted to armed state 706 from care state 704.If there is no predetermined number in channel ECG1 and ECG2 Three seconds sections of amount are classified as (no in frame 804) that can shock by electricity, then this equipment will not be converted to, from care state 704, shape of awaiting orders State 706, and it is made (frame 806) about whether changing back to the determination being indifferent to state 702.

About whether from care state 704 change back to be indifferent to state 702 really usual practice as pass through determine whether at this In at least one of two channel ECG1 and ECG2, heart rate is estimated to make less than heart rate threshold level, such as in U.S. of Zhang Institute in state patent application No.14/250,040 and in United States Patent (USP) No. United States Patent (USP) No.7,894,894 of Stadler et al. Describe, above-mentioned patent application and patent are all incorporated by reference in its entirety.If it is determined that this equipment should not be converted to being not related to Heart shaped state 702, i.e. two hearts rate estimate that both of which is more than heart rate threshold (no in frame 806), then use at next three seconds The signal generating during window is repeating this process (frame 808).If it is determined that this equipment should be converted to is indifferent to state 702, i.e. Two hearts rate estimate that both of which is more than heart rate threshold (being in frame 806), then carried out when in care state to whether on State blanking interval adjustment and be determined (frame 809).If blanking period is adjusted (being in frame 809), this equipment adjusts Described blanking interval (frame 811).For example, according to an embodiment, blanking interval can be reduced scheduled volume by this equipment, or according to another Example, it is first that this equipment can be utilized before blanking interval adjustment is returned to the adjustment occurring when this equipment is in care state Begin or nominal blanking interval setting.For example, once the operation of this equipment is converted to from care state 704 is indifferent to state 702, then If blanking interval has been adjusted to 180 milliseconds (being frames 809) from 150 milliseconds when this equipment is in care state, Blanking interval is adjusted to initial 150 millisecond setting (frame 811) by this equipment.If non-blanking period is adjusted (in frame 809 No), or Yi Dan when be in be indifferent in state when, blanking interval adjustment is returned to nominal or initial setting up (frame 811) by this equipment, Then the operation of this equipment is in and is indifferent in state (frame 702).

When this equipment when care state 704 is converted to armed state 706 (being frame 804), continue by such as in care During state using three seconds time-out trigger process.Once in standby 706, just to whether in care state Carry out above-mentioned blanking interval adjustment when in 704 and be determined (frame 810).If blanking period is adjusted (in frame 810 It is), then this equipment adjusts described blanking interval (frame 812).For example, according to an embodiment, blanking interval can be reduced pre- by this equipment Quantitative, or according to another example, blanking interval adjustment can be returned to and send out when this equipment is in care state 704 by this equipment The initial or nominal blanking interval setting being utilized before raw adjustment.For example, once the operation of this equipment is from 704 turns of state of care Change to armed state 706, then if be adjusted to blanking interval from 150 milliseconds when this equipment is in care state 704 180 milliseconds (being in frame 810), then this equipment blanking interval is adjusted to initial 150 millisecond setting (frame 812).If not right Blanking interval is adjusted (no in frame 810), or when in standby 706, blanking interval is adjusted by this equipment Return to nominal or initial setting up (frame 812), then start the charging to capacitor (frame 814).

During capacitor is charged, continuing with channel ECG1 and ECG2, section being categorized as shocking by electricity or can not Electric shock, and the blanking interval after using adjustment obtains the next one data (frame 812) of three seconds, and will pass through determination is No in both this two channel ECG1 and ECG2, the section (two such as, for example nearest sections) of predetermined quantity is classified For be can not shock by electricity whether event to be continued be can be determined (frame 816) by shock episodes.If the three of predetermined quantity seconds (show that this event may be no longer can shock episodes) that section has been classified as to shock by electricity (being in frame 816), then it be right to stop Whether capacitor charges (frame 818), and be indifferent to state 702 and be determined (frame 820) to being converted to.

According to embodiments of the invention, if meet some terminations required, this equipment will change from armed state 706 To being indifferent to state 702 (being in frame 820).For example, if for channel ECG1 and ECG2 simultaneously, last three three It is classified as less than two in second section to shock by electricity, be classified as less than three in last eight three seconds sections to shock by electricity, and Three seconds nearest sections are classified as to shock by electricity, then return to and be indifferent to state 702.It is indifferent to state for returning to 702 another possible standard is to observe 4 classification of continuously can not shocking by electricity in channel ECG1 and ECG2 simultaneously.

Outside above two standard, at least one of Current heart rate estimation must be slower than programmed heart rate threshold, And capacitor charges must not be underway.If meeting each of these requirements (being in frame 820), this sets Standby being converted to from armed state 706 is indifferent to state 702.

If one or more of these requirements are confirmed as not being satisfied, do not indicate a return to be indifferent to state (no in frame 820), and then pass through and determine whether to meet predetermined detection again and require to whether detection can again Shockable rhythm is determined (frame 822).For example, to whether in both this two channel ECG1 and ECG2 by predetermined number What three seconds sections (such as, for example nearest three in two) of amount were classified as shocking by electricity is determined.If not meeting pre- Fixed detection again requires (no in frame 822), then repeat the determination (frame 820) about whether stopped treatment delivers and make at this Reason the determination (frame 820) delivering about whether stopped treatment and about whether again detection can shock episodes determination (frame 822) switch between, until this event has terminated and this equipment is converted to from armed state 706 and is indifferent to state 702 or event Again detected.If meeting predetermined detection again to require (being in frame 822), restart charging (frame 814), and And repeat this process.

If three seconds sections of predetermined quantity are not categorized as the (frame 816 that can not shock by electricity during capacitor is charged In no), then be determined (frame 824) to whether completing the charging to capacitor.As long as capacitor charges continuing occurring (no in frame 816), just repeats this process (frame 828) using the signal generating during next three seconds windows, and once right The charging complete (being in frame 824) of capacitor, will pass through determine whether to meet predetermined treatment delivery confirmation require right Whether the delivery for the treatment of remains appropriate and is determined (frame 826).For example, according to embodiments of the invention, predetermined treatment Delivery confirmation requires to include and determines whether that, for channel ECG1 and ECG2, at least five in last eight three seconds sections are divided Class is can to shock by electricity and in last three three seconds sections at least two be classified as being and can shock by electricity.In addition, with regard to being directed to At least one of two channel ECG1 and ECG2, whether three seconds nearest sections have been classified as being being determined of can shocking by electricity.

If not meeting the delivery (no in frame 826) that predetermined treatment delivers requirement this treatment therefore unconfirmed, Repeat to whether being converted to, from armed state 706, the determination (frame 820) being indifferent to state 702.If meeting predetermined treatment Deliver the delivery (being in frame 826) requiring and therefore confirming this treatment, then this equipment is converted to electric shock from armed state 706 State 708.

It is understood that outside above three senses vectorial 102-16, optionally, also can be furthermore with virtual signal (that is, two vectorial mathematical combination), thus using more than three sensing vectors or replace described sensing vector.For example, This equipment can produce as United States Patent (USP) No.6,505,067 " the System and Method for Deriving in Lee et al. Void described in Virtual ECG or EGM Signal (system and method for deriving virtual ECG or EGM signal) " Intend vector signal；This patent is all incorporated by reference in its entirety.In addition, vector select can be selected by the doctor of patient and It is programmed via the telemetry link from programmable device.

In addition, though describe minimum signal difference use, but this equipment can be utilized for vector is carried out ranking its His selection standard.For example, according to an embodiment, this equipment can determine in the detection window for each R ripple for each vector Interior maximum signal amplitude, determines this peak swing and for the difference between the sensing threshold value of each of peak swing, and Each sensing vector is directed on 15 cardiac cycle and determines that intermediate value peak swing is poor.Then, selection is had maximum by this equipment Intermediate value peak swing difference vector as staying in during follow-up sensing and arrhythmia detection by this equipment utilization Sensing vector.According to another embodiment, the peak swing quality metric window can be deducted from maximum R wave-amplitude, or from maximum Sensing threshold value during amplitude deducts the peak swing in quality metric window.

Thus, present for selecting sensing vector to join in Medical Devices with reference to specific embodiment in the above description The method and apparatus put.It is understood that the multiple modifications to cited embodiment can be made, without departing from following right The scope of the present disclosure described in requirement.

Claims

1. a kind of Medical Devices, including：

Multiple electrodes, the plurality of electrode can form the multiple sensing vectors for sensing heart signal；And

Processor, described processor is configured to determine whether adjust blanking interval during the first mode of operation, in response to sensing To described heart signal and be advanced to the second mode of operation from described first mode of operation, when in described second mode of operation When determine whether to have adjusted described blanking interval when in described first mode of operation, and in response to when described first operate shape Have adjusted described blanking interval when in state and adjust described blanking interval when in described second mode of operation.

2. equipment as claimed in claim 1, wherein said processor is further configured to when in described first state Described blanking interval is increased to the second setting from the first setting, and by described blanking interval when in described second mode of operation It is reduced to described first setting from the described second setting.

3. equipment as claimed in claim 1, wherein said processor is further configured to when in described first state Blanking interval is increased by the first scheduled volume, and when in described second mode of operation, described blanking interval minimizing second is made a reservation for Amount, described second scheduled volume is not equal to described first scheduled volume.

4. the equipment as any one of claim 1-3, if wherein said processor is further configured to when in institute Have adjusted described blanking interval when stating in first state, then adjust described blanking interval when in described second state, and if Do not adjust described blanking interval when in described first state, then do not adjust described blanking when in described second state Phase.

5. the equipment as any one of claim 1-4, wherein said first state include determination can shock episodes whether Occurring and described second state is including treatment delivery device is charged for delivering treatment.

6. the equipment as any one of claim 1-5, where it is determined whether adjust blanking during the first mode of operation Phase includes：

It is the plurality of sensing vector setting blanking interval and blanking interval adjustment window in response to the described heart signal sensing；

Determine the first signal difference during described blanking interval adjusts window；And

In response to determined by the first signal difference and adjust described blanking interval.

7. the equipment as any one of claim 4-6, wherein determines that the first signal difference includes：

Determine the signal difference between the described heart signal sensing during described blanking interval adjusts window and sensing threshold value；And

Minimum signal in signal difference determined by determination is poor.

8. the equipment as any one of claim 4-7, wherein said processor is further configured to when described the When in one state, described blanking interval is increased to the second setting from the first setting, and will when in described second mode of operation Described blanking interval is reduced to described first setting from the described second setting.

9. equipment as described in any of claims 7, wherein said processor is further configured to work as described first When in state, described blanking interval is increased by the first scheduled volume from the first setting, and by institute when in described second mode of operation State blanking interval and reduce by the second scheduled volume, described second scheduled volume is not equal to described first scheduled volume.

10. equipment as claimed in any one of claims 1-9 wherein, if wherein said processor is further configured to when in institute Have adjusted described blanking interval when stating in first state, then adjust described blanking interval when in described second state, and if Do not adjust described blanking interval when in described first state, then do not adjust described blanking when in described second state Phase, wherein said first state include determination can shock episodes whether occurring and described second state include to treatment deliver Equipment charge is for delivering treatment.

11. equipment as any one of claim 1-10, wherein said Medical Devices include subcutaneous equipment.